ISO 14971 Assessment with eAuditor Audits & Inspections

https://eauditor.app/2025/07/04/iso-14971-checklist/

Perform ISO 14971 Assessment using eAuditor
ISO 14971 is the international standard for the application of risk management to medical devices. It provides a comprehensive framework for identifying, evaluating, controlling, and monitoring risks associated with the use of medical devices throughout their entire lifecycle—from design and development to production, post-market surveillance, and decommissioning.

ISO Checklist

Performing an ISO 14971:2019 Assessment using eAuditor allows medical device manufacturers to comprehensively audit their risk management system (RMS) to ensure it meets the latest global standards for medical device safety and effectiveness. eAuditor enables this through digital checklists, real-time documentation, team collaboration, and analytics, supporting device lifecycle risk control—from design to post-market surveillance—while maintaining regulatory readiness.

Pre-Assessment Preparation Using eAuditor
1.1 Define Assessment Scope and Context

Determine Coverage:
Evaluate risk processes across one or multiple device families.
Include all lifecycle phases: design, development, production, distribution, clinical use, and end-of-life.
Clarify Audit Objectives:
Confirm integration of ISO 14971 into the product lifecycle.
Evaluate the consistency of risk control implementation and documentation.
Identify improvement areas in current risk controls and monitoring systems.
1.2 Review Existing Risk Management Documentation

Compile necessary documentation for pre-audit preparation:

Product-specific Risk Management Plans (RMPs).
Risk analysis reports using methods like FMEA, FTA, HACCP, etc.
Hazard identification logs, including biological, electrical, software, and usability risks.
Post-market surveillance reports and field safety notices.
Benefit-risk analysis documentation.
Corrective and preventive action (CAPA) records.
Updated Risk Management Files (RMFs).
1.3 Create or Customize ISO 14971 Checklist in eAuditor

Structure the checklist according to ISO 14971’s lifecycle-based risk approach:

Risk management planning
Risk analysis and hazard identification
Acceptability criteria and Risk evaluation
Risk control and verification
Evaluation of residual risks
Benefit-risk analysis (if applicable)
Post-market feedback and risk re-evaluation
Risk documentation completeness
Checklist design:

Use Yes/No/Partial ratings and free-text commentary fields.
Embed file/photo upload sections (design drawings, lab test results, hazard logs).
Use conditional logic for critical vs. non-critical risk items.
Assign responsible persons, timelines, and priorities to findings.
Executing the ISO 14971 Audit Using eAuditor
2.1 Risk Management Planning Assessment

Is a written Risk Management Plan in place for each product?
Does it define:
Roles and responsibilities?
Risk acceptability criteria?

1. ISO 14971 Risk Assessment with
with eAuditor
ISO 14971 is the international standard for risk management in medical devices. It provides a
comprehensive framework for identifying, evaluating, controlling, and monitoring risks
throughout the entire device lifecycle—from design and development to production, post-
market surveillance, and decommissioning.
eAuditor enables digital risk management assessments through real-time documentation,
documentation, team collaboration, and analytics—ensuring regulatory readiness and device
and device safety.

2. Pre-Assessment Preparation
Define Scope
Determine coverage across device
families and all lifecycle phases: design,
design, development, production,
distribution, clinical use, and end-
of
of
-
-
life.
life.
Review Documentation
Compile Risk Management Plans, FMEA
FMEA reports, hazard logs, post-
market surveillance data, CAPA records,
market
records, and Risk Management Files.
Files.
Customize Checklist
Structure eAuditor checklist with Yes/No/Partial ratings, file uploads, conditional logic,
and assigned responsibilities for comprehensive assessment.

3. Risk Management Planning & Analysis
Planning Assessment
Verify written Risk Management Plans exist for each product, defining:
defining:
•Roles and responsibilities
•Risk acceptability criteria
•Hazard identification methods
•Post-production monitoring strategy
Hazard Identification
Ensure all potential hazards are identified:
•Intended use and foreseeable misuse
•Environmental and user interface risks
•Biological and software-related risks
•Usability engineering and human factors

4. Risk Evaluation & Control
Risk Evaluation
Evaluate risk using probability × severity metrics
metrics with standardized matrices. Flag
unacceptable risks for immediate mitigation.
mitigation.
Control Implementation
Prioritize controls: design modification (most
effective), protective measures, then user
training/warnings (least preferred).
Verification
Verify control effectiveness through testing or
simulation. Validate and document all risk
controls thoroughly.

5. Residual Risk & Benefit Analysis
Analysis
Residual Risk Evaluation
Assess residual risks after controls are applied. Compare against original risk
acceptability matrix. Implement further controls if residual risk remains too high.
high.
Benefit-Risk Analysis
For non-acceptable residual risks, document analysis demonstrating medical benefits
benefits outweigh risks. Include clinical data and performance evidence. Communicate
Communicate benefit-risk profile to users and clinicians.

6. Real-Time eAuditor Features
Evidence Capture
Use mobile devices to capture photos of devices, labeling, UI interfaces, and test
results. Upload documents directly with geotagging and timestamping for audit
verification.
Action Tracking
Convert findings into actionable tasks immediately. Assign to departments with
departments with deadlines and responsible owners. Track through the Actions
Actions Dashboard with evidence attachment.
Live Collaboration
Enable engineering, QA, and regulatory teams to update findings and actions in real
actions in real time, ensuring all stakeholders access a single source of truth.
truth.

7. Post-Audit Reporting & Monitoring
Professional Reporting
Generate comprehensive reports including:
•Compliance breakdown by ISO 14971 clause
•Supporting attachments and evidence
•Nonconformities and corrective action status
•Overall audit score and risk compliance status
Export as PDF, Excel, or online report for internal use or external reviewers.
Analytics & Insights
View trends across devices and audit periods. Spot high-risk areas with frequent
noncompliance. Track CAPA closure times and generate dashboards for presentations.
presentations.

8. Key Advantages of eAuditor
Centralized Auditing
Digitized system ensures all stakeholders access a single source of truth for risk
management documentation and compliance tracking.
Data Visualization
Track risk areas, overdue actions, and recurring safety issues through intuitive
dashboards and analytics tools.
Instant Reporting
Simplify documentation for regulators and accreditation bodies with automated,
automated, audit-ready reports and complete traceability.
Lifecycle Support
Audit history and traceability support long-term compliance and accountability
accountability throughout the entire device lifecycle.
eAuditor empowers medical device manufacturers to systematically document, verify, and improve risk identification and control—supporting not just compliance, but a safer,
compliance, but a safer, more efficient device lifecycle management approach.